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NCT00671931 · ClinicalTrials.gov registry record · Phase 1
Susceptibility of Motor-Evoked Potentials to Varying Targeted Blood Levels of Dexmedetomidine
A Phase 1 study, sponsored by Children's Hospital Medical Center, Cincinnati.
- Completed
- Registry status
- Phase 1
- Development phase
- 44
- Enrollment target
NCT00671931: Completed Phase 1 study, sponsored by Children's Hospital Medical Center, Cincinnati.
NCT00671931 is a Phase 1 study that has completed, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 44 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (27% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00671931, a Phase 1 study, has completed, sponsored by Children's Hospital Medical Center, Cincinnati.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 44 participants
- Enrollment target
Study Summary
Reduction of the spinal cord injuries during scoliosis surgery is a major goal of the anesthesia and surgical team. Despite improvement in scoliosis surgery over the years, the development of neurological deficits remains the most feared complication of spine surgery. During scoliosis surgery it is very important to monitor the spinal cord to detect spinal cord injury with surgical manipulation. Continuous or intermittent intraoperative electrophysiological monitoring (neuron-monitoring) is used routinely during these procedures to provide the surgeon with information concerning the integrity of neurological structures at risk. All neuron-monitoring modalities are affected by the anesthetic regimen used. Of the various intravenous anesthetic drugs, the combination of propofol, remifentanil and dexmedetomidine appear to impact neuron-monitoring the least. The current anesthetic practice is to use the three drugs in combination at doses that do not depress the signals but there is no data relating targeted dexmedetomidine and propofol blood levels to neuron-monitoring signals. The lack of data results in wide variability in dosing with consequent variability in patient response. Hypothesis: Clinically relevant blood levels of dexmedetomidine will affect the amplitude of transcranial motor-evoked potentials (TcMEP) either independently or by interaction with propofol in a dose dependent manner.
Primary Outcome
The primary outcome measure of the study was the participants who had Motor Evoked Potentials Amplitude significantly reduced (more than 70%)compared to the baseline.
Interventions
- DRUG Dexmedetomidine
- DRUG low dexmedetomidine, low propofol
- DRUG high dexmedetomidine, low propofol
- DRUG Dexmedetomidin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2007-04 |
| Est. Completion | 2009-01 |
| Phase | Phase 1 |
What the finished NCT00671931 record still lists
NCT00671931 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (27% lower).
The record links to 0 conditions, and to 4 interventions - of which Dexmedetomidine is the first listed.
NCT00671931 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00671931 about?
NCT00671931 is a clinical study titled "Susceptibility of Motor-Evoked Potentials to Varying Targeted Blood Levels of Dexmedetomidine". Reduction of the spinal cord injuries during scoliosis surgery is a major goal of the anesthesia and surgical team. Despite improvement in scoliosis surgery over the years, the development of neurological deficits remains the most feared complication of spine surgery. During scoliosis surgery it is ...
What is the current status of trial NCT00671931?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 44 participants. The study started on 2007-04. Estimated completion is 2009-01.
What interventions are being tested in trial NCT00671931?
The interventions under investigation include: Dexmedetomidine (DRUG), low dexmedetomidine, low propofol (DRUG), high dexmedetomidine, low propofol (DRUG), Dexmedetomidin (DRUG).
Who is sponsoring clinical trial NCT00671931?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00671931's enrollment target sits among peer trials
44 1086th of 2000 higher than 901 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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